Needle assist device and medical device

By designing the shell component, pushing component and driving component of the needle aid, the elastic potential energy of the energy storage element is used to drive the microneedle to quickly and vertically penetrate the subcutaneous tissue, solving the problem of microneedle patches being difficult to penetrate vertically in one go, and improving the reliability and compliance of drug delivery.

CN115475324BActive Publication Date: 2025-09-16SUZHOU REVEDA MEDICAL CO LTD
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Patent Information

Application Number
CN202110668202.3
Authority / Receiving Office
CN · China
Patent Type
Patents(China)
Current Assignee / Owner
Filing Date
2021-06-16
Publication Date
2025-09-16
Estimated Expiration
2041-06-16

AI Technical Summary

Technical Problem

When using a microneedle patch, it is difficult to insert all the microneedles into the subcutaneous tissue at once by manually applying it to the skin, and the force cannot be controlled when pressing multiple times, which may cause the microneedles to penetrate the skin surface non-vertically, resulting in breakage and inability to exert the drug's efficacy.

Method used

A needle assist device is designed, including a shell component, a pushing component and a driving component. The driving component drives the inner core to move from the distal end to the proximal end, so that the energy storage element stores elastic potential energy. When the potential energy is released, the inner core is driven to move from the proximal end to the distal end, pushing the needle to quickly and vertically penetrate the subcutaneous tissue.

Benefits of technology

It achieves rapid and vertical insertion of microneedles, avoids microneedle breakage, and improves the reliability and compliance of drug delivery.

✦ Generated by Eureka AI based on patent content.

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Abstract

The present invention provides a needle assist device and a medical device. The medical device includes a needle assist device, which includes a housing assembly having a first inner cavity extending axially therethrough; a push assembly disposed in the first inner cavity and including an inner core and an energy storage element; the inner core is configured to be movable axially; the energy storage element is disposed between the inner core and the housing assembly; and a drive assembly. The needle assist device is configured such that the drive assembly drives the inner core to move in a direction from distal end to proximal end and causes the energy storage element to store elastic potential energy; the drive assembly further drives the energy storage element to release the elastic potential energy and drive the inner core to move in a direction from proximal end to distal end. The needle assist device has the advantage of being simple and convenient to use.
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Description

Technical Field

[0001] The present invention relates to the technical field of medical instruments, and in particular to a needle assisting device and a medical device. Background Art

[0002] In the medical field, needle assist devices have many uses.

[0003] For patients who need to use injection needles for drug delivery, the pain caused by injection needle puncture reduces patient compliance. However, by making the needles into nano-level microneedles and forming microneedle patches in the form of microneedle arrays, the drugs can be stored in the microneedles or delivered through hollow microneedles. This can achieve painless or minimally painful drug delivery, greatly improving patient compliance, and is especially suitable for children and elderly patients.

[0004] However, when using a microneedle patch, if it is manually applied to the skin, it is difficult to insert all the microneedles into the subcutaneous tissue at one time. Pressing the patch multiple times results in uncontrollable force applied, and the microneedles may penetrate the skin non-vertically, causing the microneedles to break, making the drug ineffective and resulting in waste. Summary of the Invention

[0005] The object of the present invention is to provide a needle assisting device and a medical device, wherein the needle assisting device can provide a large thrust output so as to quickly insert a needle into the subcutaneous tissue.

[0006] To achieve the above object, the present invention provides a needle assist device, comprising:

[0007] The housing assembly has a first inner cavity extending axially therethrough;

[0008] a pushing assembly, disposed in the first inner cavity, comprising an inner core and an energy storage element; the inner core being configured to be movable in an axial direction; the energy storage element being disposed between the inner core and the outer shell assembly; and

[0009] Drive components;

[0010] The needle assist device is configured such that the drive assembly is used to drive the inner core to move in the direction from the distal end to the proximal end, and to cause the energy storage element to store elastic potential energy; the drive assembly is also used to drive the energy storage element to release the elastic potential energy, and to drive the inner core to move in the direction from the proximal end to the distal end.

[0011] Optionally, the outer shell assembly is provided with a first locking portion; the pushing assembly further comprises a second locking portion, the second locking portion being provided on the inner core and configured to remain relatively stationary with respect to the inner core in the axial direction and to be able to move relative to the inner core in the radial direction;

[0012] The needle assist device is configured such that the drive assembly is used to drive the inner core to move in the direction from the distal end to the proximal end until the second locking part is engaged and connected with the first locking part, and the drive assembly is also used to drive the second locking part to move radially relative to the inner core so that the second locking part is disconnected from the first locking part and the energy storage element releases elastic potential energy.

[0013] Optionally, the drive assembly includes a first drive member and a second drive member, the first drive member is used to drive the inner core to move from the distal end to the proximal end, and the second drive member is used to drive the second locking portion to move radially relative to the inner core.

[0014] Optionally, a first guide hole is provided on the outer shell assembly, which extends axially and is connected to the first inner cavity; the first driving member includes a coupling part and a first operating part, one end of the coupling part is connected to the inner core, and the other end passes through the first guide hole and is connected to the first operating part.

[0015] Optionally, the first locking portion includes a locking hole provided on the outer shell assembly; the inner core is provided with a first mounting hole extending radially, the first mounting hole being aligned with the locking hole in the circumferential direction; the second locking portion is at least partially provided in the first mounting hole and includes a first elastic member and an ejector pin, the ejector pin being connected to the first elastic member;

[0016] When the ejector pin extends out of the first mounting hole and is inserted into the locking hole, the second locking portion is cooperatively connected with the first locking portion. When the second driving member drives the ejector pin to move radially and compresses the first elastic member to disengage the ejector pin from the locking hole, the second locking portion is disconnected from the first locking portion.

[0017] Optionally, there are two locking holes, which are symmetrically arranged around the axis of the housing assembly; the first mounting hole extends radially through, and there are two ejector pins, which are connected by the first elastic member, and each ejector pin is formed with a wedge-shaped actuating groove;

[0018] The inner core has a second inner cavity extending in the axial direction, the proximal end of the second inner cavity is an open end, and the distal end of the second inner cavity has a bottom wall, and the bottom wall is provided with an actuating channel communicating with the first mounting hole; the second driving member is at least partially disposed in the second inner cavity and is configured to be able to move axially in the second inner cavity, and the distal end of the second driving member is formed with two oppositely disposed wedge blocks, the wedge blocks matching the shape of the actuating slot;

[0019] The needle assist device is configured such that when the second driving member moves in a direction from the proximal end to the distal end, the wedge block passes through the actuating channel and cooperates with the actuating slot to drive the two ejectors to move toward each other and compress the first elastic member.

[0020] Optionally, the groove wall of the actuating groove close to the axis of the inner core is an inclined surface, and the distance from the inclined surface to the axis of the inner core gradually increases from the proximal end to the distal end.

[0021] Optionally, the acute angle formed between the inclined surface and the axis of the inner core is 5° to 45°.

[0022] Optionally, the second driving member includes a second operating portion and the wedge block, wherein the wedge block is connected to the distal end of the second operating portion; the needle assisting device further includes a second elastic member, wherein the second elastic member is disposed between the distal end of the second operating portion and the bottom wall of the second inner cavity;

[0023] When the second driving member moves from the proximal end to the distal end, the second elastic member is compressed and stores elastic potential energy; when the second elastic member releases the elastic potential energy, the second driving member is driven to move from the distal end to the proximal end.

[0024] Optionally, the needle assisting device further includes an axial limiting member for limiting the maximum distance of axial movement of the second driving member.

[0025] Optionally, the axial limit member includes a second guide hole arranged on the side wall of the inner core and extending axially, and a guide rod arranged on the second driving member, the guide rod passes through the second guide hole and can move axially in the guide hole.

[0026] Optionally, when the second locking portion is engaged with the first locking portion, the proximal end of the second driving member extends from the proximal end of the second inner cavity, and the proximal end face of the second driving member does not protrude from the proximal end face of the outer shell assembly, and two notches are provided on the proximal end of the outer shell assembly, and the two notches are symmetrically arranged around the axis of the outer shell assembly.

[0027] Optionally, the needle assist device further includes a first circumferential limiting member for keeping the inner core and the outer shell assembly relatively stationary in the circumferential direction.

[0028] Optionally, a mounting groove extending axially is provided on the wall of the first inner cavity, and a protrusion corresponding to the mounting groove is provided on the outer surface of the inner core; the energy storage element is arranged in the mounting groove, and one end of the energy storage element abuts against the wall of the mounting groove, and the other end abuts against the protrusion.

[0029] Optionally, the shell assembly includes a shell body and a preload adjustment mechanism; the shell body includes the first inner cavity, a first positioning member is provided on the outer surface of the shell body, a third guide hole is provided on the shell body that is connected to the first inner cavity, and the third guide hole extends in the axial direction; the preload adjustment mechanism includes a third driving member, a movable sleeve and a force transmission part; the third driving member is rotatably mounted on the outer surface of the shell body, a spiral groove spirally arranged along the axis of the shell body is provided on the inner surface of the third driving member, and a second positioning member is further formed on the third driving member; the movable sleeve is mounted on the inner core, and the force transmission part is provided on the outer surface of the movable sleeve, and the force transmission part passes through the third guide hole and is inserted into the spiral groove;

[0030] A protrusion is provided on the outer surface of the inner core; one end of the energy storage element abuts against the protrusion, and the other end abuts against the movable sleeve;

[0031] The needle assist device is configured such that when the third driving member rotates in a predetermined direction around the axis of the shell body under the action of an external force, the third driving member drives the movable sleeve to move in the direction from the proximal end to the distal end, so that the energy storage element is compressed and stores elastic potential energy as a preload force; when the external force is cancelled and the second positioning member cooperates with the first positioning member, the energy storage element is prevented from releasing elastic potential energy.

[0032] Optionally, the first positioning member is a positioning groove extending along the circumference of the shell body, and at least one groove wall of the positioning groove is wavy in shape; the second positioning member is a limit block, and the contour of the limit block matches the shape of the groove wall of the positioning groove.

[0033] Optionally, the first positioning member includes a plurality of positioning grooves spaced apart along the circumference of the shell body, and the second positioning member includes a glass bead structure. When the glass bead structure is partially inserted into the positioning groove, the second positioning member cooperates with the first positioning member.

[0034] Optionally, the housing assembly further includes a second circumferential limiting member for keeping the movable sleeve and the housing body relatively stationary in the circumferential direction.

[0035] Optionally, the needle assist device further comprises an interface assembly, which is connected to the distal end of the inner core and is used to connect to a target object.

[0036] To achieve the above objectives, the present invention also provides a medical device, comprising a target object and a needle assisting device as described in any of the preceding items; the target object comprises a needle; the distal end of the inner core is used to connect with the target object and to insert the needle into a predetermined position.

[0037] Compared with the prior art, the needle assist device and medical device of the present invention have the following advantages:

[0038] The aforementioned needle assist device includes a shell assembly, a pushing assembly and a driving assembly; wherein, the shell assembly has a first inner cavity that passes axially through; the pushing assembly is arranged in the first inner cavity, and includes an inner core and an energy storage element, the inner core is configured to be able to move axially, and the distal end of the inner core is used to connect with a target object, and the target object is provided with a needle; the energy storage element is arranged between the inner core and the shell assembly; the needle assist device is configured such that the driving assembly is used to drive the inner core to move in the direction from the distal end to the proximal end, and to deform the energy storage element and store elastic potential energy, and the driving assembly is also used to drive the energy storage element to release elastic potential energy, and drive the inner core to move in the direction from the proximal end to the distal end, thereby pushing the needle on the target object to quickly penetrate the predetermined position in a vertical direction to avoid needle breakage. BRIEF DESCRIPTION OF THE DRAWINGS

[0039] The accompanying drawings are provided for a better understanding of the present invention and are not intended to limit the present invention.

[0040] Figure 1 1 is a schematic structural diagram of the needle assisting device provided according to the first embodiment of the present invention;

[0041] Figure 2 This is a schematic diagram of an explosion of the needle assist device provided in accordance with the first embodiment of the present invention;

[0042] Figure 3 1 is a partial cross-sectional view of the needle assist device according to the first embodiment of the present invention, showing a schematic diagram of the cooperation between the second driving member and the pushing assembly, and in the figure, the second locking portion is located on the distal side of the first locking portion;

[0043] Figure 4 1 is a partial cross-sectional view of the needle assist device according to the first embodiment of the present invention, showing a schematic diagram of the cooperation between the second driving member and the pushing assembly, and in which the second locking portion is cooperatively connected with the first locking portion;

[0044] Figure 5 is a partial cross-sectional view of the needle assist device provided according to the first embodiment of the present invention, showing a schematic diagram of the arrangement of the energy storage element;

[0045] Figure 6 is a partial cross-sectional view of the needle assisting device provided according to the first embodiment of the present invention, showing a schematic diagram of the axial limiting member;

[0046] Figure 7 1 is a partial cross-sectional view of the needle assist device provided according to the first embodiment of the present invention, showing a schematic diagram of the axis limiting member. Figure 7 The guide rod shown is Figure 6The guide rods shown are different;

[0047] Figure 8 1 is a schematic structural diagram of a needle assisting device according to a second embodiment of the present invention;

[0048] Figure 9 This is a schematic diagram of an explosion of the needle assisting device provided in accordance with the second embodiment of the present invention;

[0049] Figure 10 This is a partial structural diagram of the needle assisting device provided in accordance with the second embodiment of the present invention;

[0050] Figure 11 This is a schematic diagram of an explosion of the needle assisting device provided in accordance with the third embodiment of the present invention;

[0051] Figure 12 It is a partial structural diagram of the needle assisting device provided according to the third embodiment of the present invention.

[0052] [The following are the descriptions of the reference numerals]:

[0053] 1001 - first inner cavity, 1002 - first locking portion, 1003 - first guide hole, 1004 - notch, 1005 - mounting groove, 1100 - housing body, 1101 - first positioning member, 1102 - third guide hole, 1200 - preload adjustment mechanism, 1210 - third driving member, 1211 - spiral groove, 1212 - second positioning member, 1220 - movable sleeve, 1221 - second raised structure, 1230 - transmission portion;

[0054] 2000 - Pushing assembly, 2100 - Inner core, 2101 - First mounting hole, 2102 - Second inner cavity, 2103 - Second guide hole, 2110 - Protrusion, 2111 - Annular protrusion structure, 2112 - First raised structure, 2200 - Energy storage element, 2300 - Second locking portion, 2310 - First elastic member, 2320 - Ejector pin, 2321 - Actuating groove, 2322 - Ejector pin body, 2323 - Insertion section;

[0055] 3100 - first driving member, 3110 - engaging portion, 3120 - first operating portion, 3200 - second driving member, 3210 - wedge block, 3220 - guide rod, 3221 - third elastic member, 3222 - buckle, 3230 - second operating portion;

[0056] 4000-Interface component;

[0057] 5000-Second elastic member. DETAILED DESCRIPTION

[0058] The following describes the embodiments of the present invention through specific specific examples. Those skilled in the art can easily understand other advantages and effects of the present invention from the contents disclosed in this specification. The present invention can also be implemented or applied through other different specific embodiments, and the details in this specification can also be modified or changed in various ways based on different viewpoints and applications without departing from the spirit of the present invention. It should be noted that the illustrations provided in this embodiment only illustrate the basic concept of the present invention in a schematic manner, and the drawings only show components related to the present invention rather than being drawn according to the number, shape and size of components during actual implementation. During actual implementation, the type, quantity and proportion of each component can be changed at will, and the component layout type may also be more complicated.

[0059] In addition, each embodiment described below has one or more technical features. However, this does not mean that users of the present invention must implement all technical features in any embodiment at the same time, or that they can only implement some or all technical features in different embodiments separately. In other words, as long as implementation is possible, those skilled in the art can, based on the disclosure of the present invention and depending on design specifications or implementation requirements, selectively implement some or all technical features in any embodiment, or selectively implement a combination of some or all technical features in multiple embodiments, thereby increasing the flexibility of the implementation of the present invention.

[0060] As used in this specification, the singular forms "a", "an", and "the" include plural objects, and the plural form "a plurality" includes more than two objects, unless the content clearly indicates otherwise. As used in this specification, the term "or" is generally used in a sense including "and / or", unless the content clearly indicates otherwise, and the terms "installed", "connected", and "connected" should be understood in a broad sense, for example, it can be a fixed connection, a detachable connection, or an integral connection. It can be a mechanical connection or an electrical connection. It can be directly connected or indirectly connected through an intermediate medium, and it can be a connection between the internal parts of two elements or an interaction relationship between two elements. For those of ordinary skill in the art, the specific meanings of the above terms in the present invention can be understood according to the specific circumstances.

[0061] To make the objects, advantages, and features of the present invention more apparent, the present invention is further described below in detail with reference to the accompanying drawings. It should be noted that the drawings are greatly simplified and not to exact scale, and are intended solely to facilitate and clearly illustrate the embodiments of the present invention. The same or similar reference numerals in the drawings represent the same or similar components.

[0062] In this article, the terms "proximal" and "distal" refer to the relative orientation, position, and direction of components or actions relative to each other from the perspective of a doctor using the medical device. Although "distal" and "proximal" are not restrictive, the "distal" usually refers to the end closer to the patient, and the end opposite to the "distal" is the "proximal".

[0063] <Example 1>

[0064] Figure 1 This is a structural diagram of the needle assist device provided in Example 1 of the present invention. Figure 2 It is a schematic diagram of the explosion of the needle assisting device.

[0065] Please refer to Figure 1 and Figure 2 , the needle assist device includes a shell assembly, a pushing assembly 2000 and a driving assembly. The shell assembly has a first inner cavity 1001 that is axially continuous. The pushing assembly 2000 is arranged in the first inner cavity 1001 and includes an inner core 2100 and an energy storage element 2200. The inner core 2100 is configured to be able to move along the axial direction of the needle assist device. The energy storage element 2200 is arranged between the inner core 2100 and the shell assembly. The needle assist device is configured such that the driving assembly is used to drive the inner core 2100 to move in the direction from the distal end to the proximal end, so that the energy storage element 2200 is deformed and stores elastic potential energy. The driving assembly is also used to drive the energy storage element 2200 to release elastic potential energy and drive the pushing assembly 2000 to move in the direction from the proximal end to the distal end ( Figure 1 The direction indicated by the arrow is from the proximal end to the distal end).

[0066] The distal end of the inner core 2100 is used to connect to a target object (not shown), such as a needle extending axially along the needle-enhancing device. During use, the user first activates the drive assembly to store elastic potential energy in the energy storage element 2200. Then, the drive assembly is activated again to release the elastic potential energy, thereby propelling the target object along with the inner core 2100 in a rapid proximal-to-distal direction, and causing the needle to penetrate vertically into the predetermined position to prevent needle breakage. Those skilled in the art will appreciate that the predetermined position can be subcutaneous, and the needle is a convex structure with a pointed tip that can penetrate subcutaneously. The target object includes, but is not limited to, microneedle patches, needle assemblies for insulin and other drug infusion systems, and needle assemblies for blood glucose monitoring devices. It should be noted that the needle-enhancing device is typically cylindrical in structure, with its longitudinal direction being the axial direction of the needle-enhancing device and the direction perpendicular to the axial direction being the radial direction. The axial and radial directions referred to herein generally refer to the axial and radial directions of the needle-enhancing device, unless otherwise specified.

[0067] In more detail, the housing assembly is provided with a first locking portion 1002. The pushing assembly 2000 also includes a second locking portion 2300, which is disposed on the inner core 2100 and is configured to remain stationary relative to the inner core 2100 in the axial direction and to be movable radially relative to the inner core 2100. Furthermore, the drive assembly includes a first drive member 3100 and a second drive member 3200. The needle assist device is configured such that the first drive member drives the inner core 2100 in a distal-to-proximal direction until the second locking portion 2300 engages with the first locking portion 1002, thereby allowing the energy storage element 2200 to retain its stored elastic potential energy. The second drive member 3200 drives the second locking portion 2300 to move radially relative to the inner core 2100, thereby disconnecting the second locking portion 2300 from the first locking portion 1002 and releasing the elastic potential energy of the energy storage element 2200. That is, during actual use, the user first activates the first driving member 3100 and then activates the second driving member 3200 .

[0068] Alternatively, as Figure 2 As shown, the needle assist device further includes an interface assembly 4000, through which the distal end of the inner core 2100 is connected to the target object. Those skilled in the art will appreciate that the structure of the interface assembly 4000 is selected based on the specific type of target object, as long as it enables the distal end of the inner core 2100 to connect to the target object. The interface assembly 4000 can be connected to the distal end of the inner core 2100 via any suitable means, such as a snap-fit ​​structure, an interference fit, a threaded connection, or an adhesive connection.

[0069] Next, the specific structures and assembly relationships of the housing component, the pushing component 2000 and the driving component of the needle assist device provided in this embodiment are introduced.

[0070] Please continue to refer to Figure 1 Combined with Figure 2 The cross section of the housing component may be circular, triangular, rectangular or polygonal, etc. This embodiment is described by taking the cross section of the housing component as a circular one as an example.

[0071] In this embodiment, the shell assembly includes a shell body 1100, the shell body 1100 has the first inner cavity 1001, and the side wall of the shell body 1100 is provided with a first guide hole 1003 connected to the first inner cavity 1001, the first guide hole 1003 is a long strip through hole extending axially, and the first guide hole 1003 can be located at the far end of the shell body 1100.

[0072] The cross-section of the inner core 2100 matches that of the outer shell 1100, meaning that the inner core 2100 can be cylindrical and preferably coaxially disposed within the first inner cavity 1001. The inner core 2100 is connected to the outer shell 1100 via the first driver 3100. Specifically, the first driver 3100 includes a coupling portion 3110 and a first operating portion 3120. One end of the coupling portion 3110 is connected to the inner core 2100, while the other end of the coupling portion 3110 extends through the first guide hole 1003 to the exterior of the outer shell 1100 and connects to the first operating portion 3120. The first operating portion 3120 is configured to receive external force and, under the action of the external force, to move axially along the first guide hole 1003, thereby driving the inner core 2100 from distal to proximal. Those skilled in the art will appreciate that the maximum axial movement distance of the first driving member 3100 is related to the length of the first guide hole 1003, and the maximum axial movement distance of the inner core 2100 is related to the axial movement distance of the first driving member 3100. Preferably, there are two first guide holes 1003, which are symmetrically arranged around the axis of the outer shell body 1100. There are also two first driving members 3100, and the engaging portion 3110 of each first driving member 3100 passes through one of the first guide holes 1003 to connect with the inner core 2100. The provision of two first driving members 3100 ensures that the force on the inner core 2100 is more balanced and the movement is smoother.

[0073] refer to Figure 3 The inner wall of the outer shell body 1100 (i.e., the wall of the first inner cavity 1001) is provided with an axially extending mounting groove 1005 with an opening toward the distal end. The mounting groove 1005 is used to mount the energy storage fillet 200. There are preferably multiple mounting grooves 1005, which are rotationally symmetrically arranged around the axis of the outer shell body 1100. The outer surface of the inner core 2100 is provided with protrusions 2110 corresponding to the mounting grooves 1005.

[0074] The energy storage element 2200 may be an elastic element, such as a spring, and the axis of the spring is arranged parallel to the axis of the needle assist device. The energy storage element 2200 is installed in the mounting groove 1005, and one end of the energy storage element 2200 abuts against the groove wall of the mounting groove 1005, and the other end abuts against the protrusion 2110. Preferably, the number of the energy storage elements 2200 is multiple, and each energy storage element 2200 is installed in one mounting groove 1005, so that the multiple energy storage elements 2200 are arranged rotationally symmetrically around the axis of the needle assist device (such as Figure 5 The specific number of energy storage elements 2200 is selected based on actual needs. Those skilled in the art will appreciate that the greater the number of energy storage elements 2200, the greater the elastic potential energy that can be stored by all of the energy storage elements 2200. Consequently, the greater the pushing force that propels the inner core 2100 from the proximal end to the distal end, facilitating rapid subcutaneous penetration of the needle, and achieving a particularly effective effect when the target object is a microneedle patch.

[0075] Furthermore, the needle assist device further comprises a first circumferential limiting member for keeping the inner core 2100 and the outer shell assembly relatively stationary in the circumferential direction. Figure 2 As shown, the protrusion 2110 includes an annular protrusion structure 2111 and a first raised structure 2112. The annular protrusion structure 2111 extends along the circumference of the inner core 2100, and the first raised structure 2112 is disposed on the annular protrusion structure 2111. The first raised structure 2112 is at least partially embedded in the mounting groove 1005. On the one hand, it is used to abut the energy storage element 2200. On the other hand, the first raised structure 2112 also cooperates with the mounting groove 1005 to form the first circumferential limiter (that is, the first circumferential limiter includes the first raised structure 2112 and the mounting groove 1005), making the structure of the needle assist device more compact and simple. Those skilled in the art will appreciate that the protrusion 2110 can be integrally formed with the inner core 2100, or the two can be formed separately and then connected together by any suitable method such as welding or gluing.

[0076] The outer shell body 1100 is also provided with a locking hole, which serves as the first locking portion 1002. Optionally, there are two locking holes, symmetrically arranged around the axis of the outer shell body 1100. The inner core 2100 is provided with a first mounting hole 2101. Preferably, the first mounting hole 2101 extends radially through the needle assist device, with the ends of the first mounting hole 2101 aligned with the two locking holes circumferentially. The second locking portion 2300 is at least partially disposed within the first mounting hole 2101 and includes a first elastic member 2310 and a ejector pin 2320. Preferably, there are two ejector pins 2320, one connected to each end of the first elastic member 2310. The two ejector pins 2320 can extend from either end of the first mounting hole 2101.

[0077] Before actuating the first driving member 3100, the first mounting hole 2101 and the second locking portion 2300 mounted thereto are located distally of the locking hole. The ejector pin 2320 is subjected to pressure from the walls of the first inner cavity 1001, squeezing the first elastic member 2310, causing the first elastic member 2310 to enter a compressed state and store elastic potential energy. As the first driving member 3100 drives the inner core 2100 in a distal-to-proximal direction, the second locking portion 2300 moves accordingly, gradually approaching the first mounting hole 2101. When the second locking portion 2300 reaches the first mounting hole 2101, the ejector pin 2320 is no longer subjected to pressure from the walls of the first inner cavity 1001. Consequently, the first elastic member 2310 releases its elastic potential energy and extends, allowing the ejector pin 2320 to extend out of the first mounting hole 2101 and into the corresponding locking hole, thereby mating and connecting the second locking portion 2300 with the first locking portion 1002. When the second driving member 3200 drives the ejector 2320 to move radially along the needle assisting device and compresses the first elastic member 2310, so that the ejector 2320 is disengaged from the locking hole, the second locking portion 2300 is disconnected from the first locking portion 1002. The first elastic member 2310 includes but is not limited to a spring.

[0078] For more details, please refer to Figures 2 to 4 , the inner core 2100 is further provided with a second inner cavity 2102, which extends axially and is located on the proximal side of the first mounting hole 2101. The proximal end of the second inner cavity 2102 is an open end, and the distal end of the second inner cavity 2102 has a bottom wall, and the bottom wall is provided with an actuating channel connected to the second inner cavity 2102. A wedge-shaped actuating groove 2321 is formed on the ejector pin 2320. The second driving member 3200 is at least partially disposed in the second inner cavity 2102 and is configured to be able to move axially under the action of an external force. Two wedge blocks 3210 arranged opposite to each other are formed at the distal end of the second driving member 3200, and the shape of the wedge blocks 3210 matches the shape of the actuating groove 2321. When the second driving member 3200 moves from the proximal end to the distal end under the action of external force, the wedge block 3210 passes through the actuating channel and cooperates with the actuating slot 2321 to drive the two ejector pins 2320 to move relative to each other and compress the first elastic member 2310, thereby causing the ejector pins 2320 to disengage from the locking hole.

[0079] In this embodiment, the wall of the actuating slot 2321 near the axis of the inner core 2100 is an inclined surface, and the distance from the inclined surface to the axis of the inner core 2100 gradually increases from the proximal end to the distal end. The acute angle formed between the inclined surface and the axis of the inner core 2100 is in the range of 5° to 45°, for example, 20°.

[0080] Preferably, the ejector pin 2320 includes an ejector pin body 2322 and an insertion section 2323. The ejector pin body 2322 is provided with the actuating slot 2321. The cross-sectional area of ​​the ejector pin body 2322 is larger than the cross-sectional area of ​​the locking hole, while the cross-sectional area of ​​the insertion section 2323 is smaller than the cross-sectional area of ​​the locking hole, allowing the insertion section 2323 to be inserted into the locking hole. This prevents the second locking portion 2300 from separating from the inner core 2100 and the outer shell 1100 at the locking hole. Furthermore, to prevent the ejector pin 2320 from rotating, the cross-sectional area of ​​the ejector pin 2320 is preferably non-circular, and accordingly, the cross-sectional area of ​​the locking hole is also non-circular.

[0081] Furthermore, the needle assist device further comprises an axial limiter for limiting the maximum distance of axial movement of the second driving member 3200. In a non-limiting embodiment, please refer to Figure 6 and Figure 7 The axial limiter includes a second guide hole 2103 provided on the side wall of the inner core 2100 and a guide rod 3220 provided on the second driving member 3200. The second guide hole 2103 is an elongated, axially extending hole. The guide rod 3220 passes through the second guide hole 2103 and moves axially under the restriction of the second guide hole 2103. The maximum axial movement distance of the second driving member 3200 is related to the length of the second guide hole 2102.

[0082] Optionally, the number of the second guide holes 2103 is two, and the two second guide holes 2103 are symmetrically arranged around the circumference of the inner core 2100. The guide rod 3220 can be a long pin (such as Figure 6 As shown in the figure), the long pin passes through the second driving member 3200 in the radial direction, and the two ends of the long pin pass through a second guide hole 2103 respectively. Alternatively, the guide rod 3220 includes two short pins, each of which is connected to the second driving member 3200, and the end of each short pin away from the second driving member 3200 passes through a second guide hole 2103. Alternatively, the second driving member 3200 is provided with two second mounting holes (not marked in the figure), and the two second mounting holes are symmetrically arranged around the axis of the second driving member 3200. The guide rod 3220 includes two elastic pins (as shown in the figure). Figure 2 and Figure 7Each elastic pin includes a third elastic member 3221 and a buckle 3222. The buckle 3222 is connected to the second mounting hole via the third elastic member 3221. The end of the buckle 3222, away from the third elastic member 3221, passes through one of the second guide holes 2103. The guide rod 3220 cooperates with the two second guide holes 2103 to improve the force balance of the guide rod 3220.

[0083] Further, please refer back to Figure 2 Combined with Figure 3 and Figure 4 The second driving member 3200 includes a second operating portion 3230 and a wedge block 3210, wherein the wedge block 3210 is connected to the distal end of the second operating portion 3230. The needle assist device further includes a second elastic member 5000, such as a spring, which is disposed between the distal end of the second operating portion 3230 and the bottom wall of the second inner cavity 201. When the second driving member 3200 moves from the proximal end to the distal end under the action of an external force to release the connection between the second locking portion 2300 and the first locking portion 1002, the second elastic member 5000 is compressed and stores elastic potential energy. When the external force is removed, the second elastic member 5000 releases the elastic potential energy and drives the second driving member 3200 to move from the distal end to the proximal end, thereby achieving reset.

[0084] In addition, please refer to Figure 1 When the second locking portion 2300 is mated with the first locking portion 1002, the proximal end of the second driving member 3200 extends from the proximal end of the second inner cavity 2102, and the proximal end face of the second driving member 3200 does not protrude from the proximal end face of the outer shell body 1100 (that is, the proximal end face of the second driving member 3200 is located on the proximal side of the proximal end face of the inner core 2100, and the proximal end face of the second driving member 3200 is flush with the proximal end face of the outer shell body 1100 or the proximal end face of the second driving member 3200 is located on the distal side of the proximal end face of the outer shell body 1100). Correspondingly, the proximal end of the shell body 1100 is provided with two notches 1004, and the two notches 1004 are rotationally symmetrically arranged around the axis of the shell body 1100. In this way, the user can conveniently apply external force to the second driving member 3200 from the notches 1004 to drive the second driving member 3200 to move axially, and can also prevent misoperation to a certain extent.

[0085] The needle-assisting device is used as follows: First, the target object is connected to the distal end of the inner core 2100 via the interface assembly 4000. Next, the user applies an external force to the first operating portion 3120, causing the first driver 3100 to move the inner core 2100 from distal to proximal, and causing the energy storage element 2200 to store elastic potential energy until the second locking portion 2300 engages with the first locking portion 1002. Next, the distal end of the needle-assisting device is aligned with the patient's body surface, so that the needle is perpendicular to the patient's body surface. Next, the user applies an external force to the second operating portion 3230 at the notch 1004 of the outer shell assembly, causing the second driver 3200 to move from proximal to distal, disconnecting the second locking portion 2300 from the first locking portion 1002. The energy storage element 2200 releases its elastic potential energy and rapidly propels the inner core 2100, carrying the target object, from proximal to distal, allowing the needle to quickly penetrate the skin. At the same time, the first driving member 3100 returns to its initial position, and the second driving member 3200 also returns to its initial position under the action of the second elastic member 5000. Finally, the interface assembly 4000 and the target object are separated.

[0086] The needle assist device provided in this embodiment is convenient for the user to hold and operate with one hand, making it more convenient and simple to use. The needle assist device has high stability and can utilize multiple energy storage elements to provide a large pushing force to effectively insert the needle of the target object into the subcutaneous tissue.

[0087] Furthermore, this embodiment also provides a medical device, comprising the aforementioned needle assisting device and a target object, wherein the target object is connected to the distal end of the inner core.

[0088] <Example 2>

[0089] Please refer to Figures 8 to 10 The difference between this embodiment and the first embodiment is that the housing assembly includes not only the housing body 1100 but also a preload adjustment mechanism 1200 .

[0090] Specifically, a first positioning member 1101 and a third guide hole 1102 are provided on the outer surface of the shell body 1100. The third guide hole 1102 is connected to the first inner cavity 1001 and extends in the axial direction. The third guide hole 1102 is preferably located between the first positioning member 1101 and the first guide hole 1003. The preload adjustment mechanism 1200 includes a third driving member 1210, a movable sleeve 1220 and a force transmission portion 1230. The third driving member 1210 is sleeved on the outside of the shell body 1100 and is configured to remain relatively stationary with the shell body 1100 in the axial direction and to be able to perform circumferential rotational motion around the shell body 1100. A spiral groove 1211 is provided on the inner surface of the third driving member 1210, spirally encircling the axis of the shell body 1100. The cross-section of the spiral groove 1211 can be rectangular or trapezoidal. The third driving member 1210 is further formed with a second positioning member 1212, which is configured to engage with the first positioning member 1101. The movable sleeve 1220 is disposed within the first inner cavity 1001 and is sleeved onto the inner core 2100, and is configured to move axially. The force transmission portion 1230 is connected to the outer surface of the movable sleeve 1220, passes through the third guide hole 1102, and is inserted into the spiral groove 1211.

[0091] In addition, the mounting groove is no longer provided on the inner surface of the housing body 1100. One end of the energy storage element 2200 abuts against the movable sleeve 1220, and the other end abuts against the protrusion 2110.

[0092] In this embodiment, before actuating the first driving member 1210, when the third driving member 1210 rotates in a predetermined direction around the axis of the shell body 1100 under the action of an external force, the third driving member 1210 drives the movable sleeve 1220 to move in the axial direction of the needle aid from the proximal end to the distal end through the force transmission part 1230, so that the energy storage element is compressed and stores elastic potential energy, which can be used as a preload. When the external force is canceled and the second positioning member 1212 is connected to the first positioning member 1101, the energy storage element is prevented from releasing the preload. The predetermined direction can be clockwise or counterclockwise, depending on the actual situation. In addition, the magnitude of the preload can be adjusted by adjusting the number of rotations of the second driving member 1210.

[0093] Optionally, there are two force transmission parts 1230, and the two force transmission parts 1230 are spaced 180° apart in the circumferential direction of the needle assist device, and the distance between them in the axial direction of the needle assist device is 0.5 times the pitch of the spiral groove 1211. In this way, the force on the movable sleeve 1220 is more balanced, avoiding tilting. The second positioning member 1212 can be separately formed from the third driving member 1210 and then connected by interference fit (in this case, the third driving member 1210 is provided with a third mounting hole), glue bonding, snap connection or any other suitable method.

[0094] Optionally, the first positioning member 1101 is a positioning groove extending along the circumference of the housing body 1100, with at least one groove wall of the positioning groove being wavy in shape. The second positioning member 1212 is a stopper, and the contour of the stopper matches the shape of the groove wall of the positioning groove. When the user rotates the third driving member 1210, the stopper slides along the wavy groove wall of the positioning groove, providing a tactile feedback effect.

[0095] In this embodiment, the needle assist device also includes a first circumferential stopper, which may include a first raised structure 2112 on the protrusion 2110 and a first groove (not shown) provided on the inner surface of the housing body 1100. Furthermore, the needle assist device also includes a second circumferential stopper, which is used to maintain the movable sleeve 1220 and the housing body 1100 in relative circumferential position. A second raised structure 1221 may be formed on the movable sleeve 1220, and a second groove (not shown) may be provided on the inner surface of the housing body 1100 to mate with the second raised structure 1221. When the second raised structure 1221 is at least partially embedded in the second groove, the second raised structure 1221 and the second groove may constitute the second circumferential stopper. Those skilled in the art will appreciate that when the first raised structure 2112 and the second raised structure 1221 are aligned circumferentially of the needle assist device, the first and second grooves may communicate. Furthermore, two ends of the energy storage element 2200 may respectively rest against the first raised structure 2112 and the second raised structure 1221 .

[0096] The needle assist device provided in this embodiment is used as follows: First, the distal end of the inner core 2100 is connected to the target object via the interface assembly 4000. Next, the third driver 1210 is rotated to cause the energy storage element 2200 to store elastic potential energy and exert a preload. Next, the first driver 3100 is actuated to further deform the energy storage element 2200 and store elastic potential energy. Next, the needle of the target object is aligned vertically with the patient's body surface, and the second driver 3200 is actuated to release all elastic potential energy from the energy storage element 2200, allowing the needle of the target object to penetrate the subcutaneous tissue. Finally, the target object and the interface assembly 4000 are separated. Compared to Example 1, even with the same number of energy storage elements 2200, the greater deformation of the energy storage element 2200 results in a greater thrust force, resulting in a greater impact force on the needle and faster subcutaneous penetration. This makes it more suitable for use on targets requiring high thrust.

[0097] Furthermore, this embodiment also provides a medical device, comprising the aforementioned needle assisting device and a target object, wherein the target object is connected to the distal end of the inner core.

[0098] <Example 3>

[0099] The difference between this embodiment and the second embodiment lies in the different structures of the first positioning member 1101 and the second positioning member 1212 .

[0100] like Figure 11 and Figure 12 As shown, in this embodiment, the first positioning member 1101 includes a plurality of positioning grooves spaced apart along the circumference of the shell body 1100, and the positioning grooves are hemispherical in shape. The second positioning member 1212 is a glass bead structure. Those skilled in the art should know that the glass bead structure is a prior art, which generally includes a compression spring and a steel ball connected to the compression spring. When the second positioning member 1212 rotates to one of the positioning grooves along with the third driving member 1210, the steel ball is inserted into the positioning groove under the action of the compression spring. At this time, the second positioning member 1212 cooperates with the first positioning member 1101. The glass bead structure can be connected to the third driving member 1210 through a positioning block. In addition, a limiting groove extending along its circumference is provided on the outer surface of the shell body 1100, and the positioning groove can be set in the limiting groove.

[0101] Furthermore, this embodiment also provides a medical device, comprising the aforementioned needle assisting device and a target object, wherein the target object is connected to the distal end of the inner core.

[0102] While the present invention is disclosed above, it is not limited thereto. Those skilled in the art may make various modifications and variations to the present invention without departing from the spirit and scope of the present invention. Thus, the present invention is intended to encompass such modifications and variations as long as they fall within the scope of the claims and their equivalents.

Claims

1. A needle assist device, characterized in that: include: The housing assembly has a first inner cavity extending axially therethrough; the housing assembly is provided with a first locking portion, the first locking portion including a locking hole provided on the housing assembly; A pushing assembly is arranged in the first inner cavity, comprising an inner core, an energy storage element and a second locking portion; the inner core is configured to be able to move in the axial direction; a first mounting hole extending in the radial direction is provided on the inner core, and the first mounting hole is aligned with the locking hole in the circumferential direction; the energy storage element is arranged between the inner core and the outer shell assembly; the second locking portion is arranged on the inner core, and is configured to remain relatively stationary with the inner core in the axial direction and be able to move radially relative to the inner core, the second locking portion is at least partially arranged in the first mounting hole, and comprises a first elastic member and a ejector pin, the ejector pin is connected to the first elastic member; and, The drive assembly includes a first drive member and a second drive member; the first drive member is used to drive the inner core to move from the distal end to the proximal end until the ejector pin extends out of the first mounting hole and is inserted into the locking hole, so that the second locking portion is cooperated with the first locking portion and the energy storage element stores elastic potential energy; the second drive member is used to drive the ejector pin to move radially and compress the first elastic member, so that the ejector pin is disengaged from the locking hole and the second locking portion is disconnected from the first locking portion, thereby causing the energy storage element to release the elastic potential energy to drive the inner core to move from the proximal end to the distal end.

2. The needle assist device according to claim 1, characterized in that: A first guide hole is provided on the outer shell assembly, which extends axially and is connected to the first inner cavity; the first driving member includes a coupling part and a first operating part, one end of the coupling part is connected to the inner core, and the other end passes through the first guide hole and is connected to the first operating part.

3. The needle assist device according to claim 1, characterized in that: There are two locking holes, which are symmetrically arranged around the axis of the housing assembly; the first mounting hole extends radially through, and there are two ejector pins, which are connected by the first elastic member, and each ejector pin is formed with a wedge-shaped actuating groove; The inner core has a second inner cavity extending in the axial direction, the proximal end of the second inner cavity is an open end, the distal end of the second inner cavity has a bottom wall, and the bottom wall is provided with an actuating channel communicating with the first mounting hole; The second driving member is at least partially disposed in the second inner cavity and is configured to be able to move axially in the second inner cavity, and two oppositely disposed wedge blocks are formed at the distal end of the second driving member, and the wedge blocks match the shape of the actuating slot; The needle assist device is configured such that when the second driving member moves in a direction from the proximal end to the distal end, the wedge block passes through the actuating channel and cooperates with the actuating slot to drive the two ejectors to move toward each other and compress the first elastic member.

4. The needle assist device according to claim 3, characterized in that: The groove wall of the actuating groove close to the axis of the inner core is an inclined surface, and the distance from the inclined surface to the axis of the inner core gradually increases from the proximal end to the distal end.

5. The needle assist device according to claim 4, characterized in that: The acute angle formed between the inclined surface and the axis of the inner core is 5° to 45°.

6. The needle assist device according to claim 3, characterized in that: The second driving member includes a second operating portion and the wedge block, wherein the wedge block is connected to the distal end of the second operating portion; the needle assisting device further includes a second elastic member, which is disposed between the distal end of the second operating portion and the bottom wall of the second inner cavity; When the second driving member moves from the proximal end to the distal end, the second elastic member is compressed and stores elastic potential energy; when the second elastic member releases the elastic potential energy, the second driving member is driven to move from the distal end to the proximal end.

7. The needle assist device according to claim 3, characterized in that: The needle assist device further includes an axial limiter for limiting the maximum distance of axial movement of the second driving member.

8. The needle assist device according to claim 7, characterized in that: The axial limiting member includes a second guide hole provided on the side wall of the inner core and extending axially, and a guide rod provided on the second driving member. The guide rod passes through the second guide hole and can move axially in the guide hole.

9. The needle assist device according to claim 3, characterized in that: When the second locking portion is engaged with the first locking portion, the proximal end of the second driving member extends from the proximal end of the second inner cavity, and the proximal end face of the second driving member does not protrude from the proximal end face of the outer shell component. Two notches are provided on the proximal end of the outer shell component, and the two notches are symmetrically arranged around the axis of the outer shell component.

10. The needle assist device according to any one of claims 1 to 9, characterized in that: The needle assist device further includes a first circumferential limiting member for keeping the inner core and the outer shell assembly relatively stationary in the circumferential direction.

11. The needle assist device according to claim 1, characterized in that: A mounting groove extending axially is provided on the cavity wall of the first inner cavity, and a protrusion corresponding to the mounting groove is provided on the outer surface of the inner core; the energy storage element is arranged in the mounting groove, and one end of the energy storage element abuts against the groove wall of the mounting groove, and the other end abuts against the protrusion.

12. The needle assist device according to claim 1, characterized in that: The shell assembly includes a shell body and a preload adjustment mechanism; the shell body includes the first inner cavity, a first positioning member is provided on the outer surface of the shell body, a third guide hole is provided on the shell body that is connected to the first inner cavity, and the third guide hole extends axially; the preload adjustment mechanism includes a third driving member, a movable sleeve and a force transmission part; the third driving member is rotatably mounted on the outer surface of the shell body, a spiral groove is provided on the inner surface of the third driving member that spirally surrounds the axis of the shell body, and a second positioning member is also formed on the third driving member; the movable sleeve is mounted on the inner core, and the force transmission part is provided on the outer surface of the movable sleeve, and the force transmission part passes through the third guide hole and is inserted into the spiral groove; A protrusion is provided on the outer surface of the inner core; one end of the energy storage element abuts against the protrusion, and the other end abuts against the movable sleeve; The needle assist device is configured such that when the third driving member rotates in a predetermined direction around the axis of the shell body under the action of an external force, the third driving member drives the movable sleeve to move in the direction from the proximal end to the distal end, so that the energy storage element is compressed and stores elastic potential energy as a preload force; when the external force is cancelled and the second positioning member cooperates with the first positioning member, the energy storage element is prevented from releasing elastic potential energy.

13. The needle assisting device according to claim 12, characterized in that: The first positioning member is a positioning groove extending along the circumference of the shell body, and at least one groove wall of the positioning groove is wavy in shape; the second positioning member is a limit block, and the contour of the limit block matches the shape of the groove wall of the positioning groove.

14. The needle assist device according to claim 12, characterized in that: The first positioning member includes a plurality of positioning grooves spaced apart along the circumference of the shell body, and the second positioning member includes a glass bead structure. When the glass bead structure is partially inserted into the positioning groove, the second positioning member cooperates with the first positioning member.

15. The needle assisting device according to claim 12, characterized in that: The housing assembly further includes a second circumferential limiting member for keeping the movable sleeve and the housing body relatively stationary in the circumferential direction.

16. The needle assist device according to claim 1, characterized in that: The needle assist device further comprises an interface component, which is connected to the distal end of the inner core and is used for connecting with a target object.

17. A medical device, characterized in that: It comprises a target object and the needle assisting device according to any one of claims 1 to 16; the target object comprises a needle; the distal end of the inner core is used to connect with the target object and to insert the needle into a predetermined position.

Citation Information

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